Description and Brand Names

US Brand Name

Fuzeon

Descriptions

Enfuvirtide is used, in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Enfuvirtide will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Enfuvirtide will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been studied in children ages 6 to 16 years old and it is not expected to cause different effects than it does in adult patients.

Geriatric

Many medicines have not been studied specifically in older people and it may not be known if they work the same way they do in younger adults.

Pregnancy

Information about this enfuvirtide-subcutaneous-route

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Tipranavir

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Infections—When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor .

Pneumonia risk factors, such as:

Cigarette smoking or

Immune system blood tests (abnormal) or

Intravenous drug use or

Lung disease (history of)—Patients with these conditions may have an increased chance of getting bacterial pneumonia

Proper Use

It is very important that you read the information for patients and the injection instructions very carefully. Ask your healthcare professional if you have any questions.

Enfuvirtide can be given by a health care professional. However, medicines given by injection are sometimes used at home. If you will be using enfuvirtide at home, your health care professional will teach you how to get the medicine ready for injection and how the injections are to be given. Be certain that you understand exactly how to get the medicine ready for injection and how the medicine is to be injected. Do not reuse needles and syringes.

You will be shown the body areas where this shot can be given. It is usually given under the skin by injection in the upper arm, upper leg or stomach. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not give yourself a shot near your elbow, knee, groin, lower or inner buttocks, into your navel (belly button), or into any skin where you have a mole, scar, bruise, tattoos, or burn sites .

This medicine comes as a powder that must be mixed with a special liquid before using. Use only the sterile water that came with your medicine to prepare it. Do not shake the medicine after adding the water. Gently tap the vial for 10 seconds and then roll it between your hands to avoid foaming. Wait for the powdered medicine to completely dissolve in the water before using it. This may take up to 45 minutes. Before using the medicine, make sure the solution is clear, colorless, and without bubbles .

Put used needles and syringes in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

It is important to take enfuvirtide as part of a combination treatment. Be sure to take all the medicines your doctor has prescribed for you, including enfuvirtide.

Do not stop taking this medicine without checking with your doctor first.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For parenteral dosage form (injection):

For treatment of HIV infection:

Adults—90 milligrams (mg) twice a day given by injection.

Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store reconstituted solution (mixed with water) in the refrigerator and use within 24 hours.

Precautions

It is very important that your doctor check you at regular visits.

You should not breast-feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk .

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone .

This medicine may cause a severe allergic reaction in some patients. Stop taking this medicine and check with your doctor immediately if you notice cough; difficulty breathing; fever; skin rash; or unusual tiredness or weakness .

This medicine may increase the chance of bacterial pneumonia in some patients. Stop taking this medicine and check with your doctor immediately if you notice cough with fever; difficulty breathing; fast breathing; or shortness of breath .

This medicine can cause reactions at the place on your body where it was injected. Almost all people get injection site reactions with enfuvirtide. These reactions hurt and itch, and they are usually mild to moderate but can occasionally be severe. These reactions generally happen within the first week of treatment and usually happen again as you keep using enfuvirtide. If the injection site nodules drain pus or cause redness that spreads or streaks from the sites, or you are worried about the reaction you are having, call your doctor right away .

Some people who have used Biojector® 2000 to inject this medicine have had shooting nerve pain and tingling lasting up to 6 months when injected close to large nerves or near joints, or had bleeding, bruising, or lumps. Ask your doctor about this if you are concerned before you use the device .

This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

itching, pain, redness, swelling, tenderness, or warmth on skin at injection site

loss of appetite

lump or growth on skin

nausea

pains in stomach, side, or abdomen, possibly radiating to the back

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

vomiting

yellow eyes or skin

Rare

Difficulty in breathing or swallowing

fast heartbeat

skin itching, rash, or redness

swelling of face, throat, or tongue

Incidence not known

Black, tarry stools

bleeding gums

blood in urine or stools

bloody urine

chest pain

decreased frequency or amount of urine

inability to move arms and legs

increased blood pressure

increased thirst

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on skin

sneezing

sore throat

sudden numbness and weakness in the arms and legs

swelling of face, fingers, lower legs; weight gain

ulcers, sores, or white spots in mouth

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal growth filled with fluid or semisolid material

bruising

burning or stinging of skin

decreased appetite

diarrhea

discouragement

dry mouth

fear

feeling sad or empty

flushing

hard lump

irritability

itching skin

lack of appetite

lack or loss of strength

large, flat, blue or purplish patches in the skin

muscle pain

nervousness

painful cold sores or blisters on lips, nose, eyes, or genitals

redness of skin

small lumps under the skin

tiredness

trouble concentrating

trouble sleeping

unusually warm skin

weight loss

Less common

Bad, unusual, or unpleasant (after) taste

burning, itching, and pain in hairy areas

change in taste

diarrhea

general feeling of discomfort or illness

joint pain

pus at root of hair

stomach pain

swollen, painful, or tender lymph glands in neck, armpit, or groin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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